BSI — Post-Market Surveillance and Vigilance Under EU MDR

White Paper BSI Group (NB 2797) 2023-11-01
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Summary

BSI guide explaining post-market surveillance requirements under EU MDR, including PMS plans, Periodic Safety Update Reports (PSUR), trend reporting, and vigilance obligations. Covers MDR Articles 83-92 and practical implementation guidance.

Document Details

Document IDBSI-PMS-VIGILANCE
TypeWhite Paper
AuthorityBSI Group (NB 2797)
Publication Date2023-11-01

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TypeWhite Paper
Published ByBSI Group (NB 2797)
Date2023-11-01

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